title: Arzoxifene versus raloxifene: effect on bone and safety parameters in postmenopausal women with osteoporosis.
abstract: Arzoxifene increased bone mineral density and decreased bone turnover to a significantly greater extent than raloxifene. The hot flush incidence was lower with arzoxifene than raloxifene.
  
  
  BACKGROUND
  To assess the effect of arzoxifene versus raloxifene on change in lumbar spine (LS) bone mineral density (BMD) in postmenopausal women with osteoporosis.
  
  
  METHODS
  In this 12-month study (NEXT trial), participants were randomly assigned to arzoxifene 20 mg/day (N = 158) or raloxifene 60 mg/day (N = 162). All received daily calcium and vitamin D. Change in LS BMD was assessed by DXA. Secondary objectives included assessment of femoral neck (FN) and total hip BMD, serum bone turnover markers, and safety.
  
  
  RESULTS
  Treatment groups were similar at baseline (mean age 63 years, mean LS BMD T-score -2.9). At 12 months, the increase in LS BMD with arzoxifene was greater than with raloxifene (+2.75% vs. +1.66%), as was FN and total hip BMD (P < 0.05). For LS and FN, this effect was also evident at 6 months. Arzoxifene reduced bone turnover to a greater extent than raloxifene at 3, 6, and 12 months (P < 0.05). The proportion of women reporting ≥ 1 adverse event did not differ between treatment groups, nor did vaginal bleeding. No cases of endometrial polyps, hyperplasia, or cancer were reported. Nasopharyngitis and bronchitis were reported more frequently with arzoxifene versus raloxifene (10.1% vs. 2.5%, and 5.1% vs. 0%, respectively) and new/worsening hot flushes were reported less frequently with arzoxifene (7.0% vs. 16.7%) (P < 0.05).
  
  
  CONCLUSIONS
  Arzoxifene increased BMD and suppressed bone turnover to a greater extent than raloxifene and resulted in a lower incidence of new/worsening hot flushes. Based on subsequent findings from a fracture outcome study, this difference did not translate into improved fracture efficacy.
authors.affiliation: University of British Columbia, 600-1285 West Broadway, Vancouver, BC, Canada V6H 3X8. kendler@ca.inter.net
authors.forename: D L
authors.initials: DL
authors.lastname: Kendler
authors.forename: S
authors.initials: S
authors.lastname: Palacios
authors.forename: D A
authors.initials: DA
authors.lastname: Cox
authors.forename: J
authors.initials: J
authors.lastname: Stock
authors.forename: J
authors.initials: J
authors.lastname: Alam
authors.forename: S A
authors.initials: SA
authors.lastname: Dowsett
authors.forename: J
authors.initials: J
authors.lastname: Zanchetta
mesh_terms: D015502:Absorptiometry, Photon / Q000379:methods; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006621:Hip Joint / Q000503:physiopathology; D019584:Hot Flashes / Q000139:chemically induced; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology; D010880:Piperidines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D010880:Piperidines; D013876:Thiophenes; D020849:Raloxifene Hydrochloride; C115121:LY 353381